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Virus Therapy

SAB-176 for Flu (SAB-176-103 Trial)

Phase 1
Recruiting
Led By Nehkonti Adams, MD
Research Sponsored by SAb Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment
Be between 18 and 65 years old
Must not have
Receipt of pooled immunoglobulin or plasma within 30 days prior to planned dosing
Chronic asthma requiring the use of oral steroids or hospitalization in the last six months; inhaled steroids are permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour post dose, day 1, day 8, day 14, day 28, day 60
Awards & highlights

Summary

This trial will test the safety and tolerance of an injection called SAB-176 for preventing and treating the flu. It will involve 28 participants who will receive either the injection or a placebo. The

Who is the study for?
Healthy adults who can receive an intramuscular injection are eligible for this trial. The study is not suitable for individuals with certain health conditions, but specific exclusion criteria are not listed.
What is being tested?
The trial is testing SAB-176, a potential flu prevention treatment given by injection, against a placebo (saline solution). It's in Phase 1 with dose escalation to ensure safety before increasing the amount given to participants.
What are the potential side effects?
Since it's a Phase 1 trial focusing on safety and tolerability, side effects are being closely monitored but have not been specified. Common reactions may include pain at the injection site or mild flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy adult between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received any immunoglobulin or plasma treatments in the last 30 days.
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I have asthma that needed oral steroids or hospital care recently.
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I haven't received any experimental vaccines in the last 30 days.
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I was hospitalized for a severe flu within the last 30 days.
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I am not on drugs that weaken my immune system and do not have an immune deficiency.
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I have an autoimmune disease needing strong medication in the last 6 months.
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I have a chronic lung condition that requires me to use extra oxygen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour post dose, day 1, day 8, day 14, day 28, day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour post dose, day 1, day 8, day 14, day 28, day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of IP-related unsolicited AEs through Day 61.
Occurrence of serious adverse events (SAEs) through Day 61.
Occurrence of solicited local and systemic adverse events (AEs) through Day 29.
Secondary outcome measures
Area under the curve (AUC)
Hemagglutination Inhibition (HAI) against influenza A strains (H1N1, H3N2)
Hemagglutination Inhibition (HAI) against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
+6 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: SAB-176 5mLExperimental Treatment1 Intervention
5 mL (\~375 mg) SAB-176 dose
Group II: SAB-176 3mLExperimental Treatment1 Intervention
3 mL (\~225 mg) SAB-176 dose
Group III: SAB-176 20mLExperimental Treatment1 Intervention
20 mL (\~1500 mg) SAB-176 dose
Group IV: SAB-176 1 mLExperimental Treatment1 Intervention
1 mL (\~75 mg) SAB-176 dose
Group V: Placebo 1mLPlacebo Group1 Intervention
Normal Saline
Group VI: Placebo 20mLPlacebo Group1 Intervention
Normal Saline
Group VII: Placebo 3mLPlacebo Group1 Intervention
Normal Saline
Group VIII: Placebo 5mLPlacebo Group1 Intervention
Normal Saline

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SAb Biotherapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
4,220 Total Patients Enrolled
Nehkonti Adams, MDPrincipal InvestigatorNaval Medical Research Command (NMRC)
~16 spots leftby Feb 2025
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